Prospective and Multicentric Cohort Study of Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil (SCOPe).

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Chronic obstructive pulmonary disease (COPD) is prevalent (8-20%) and is one of the leading causes of mortality. In 2019 according to WHO it was the third highest cause of death worldwide. In 2019 in Brazil respiratory diseases (Chapter J in the ICD10) were the third cause of death (176.073) with COPD (J44) accounting for 45.163 deaths (25,6% of respiratory and 3% overall). There is an upward trend for COPD mortality worldwide. The disease also has a high morbidity leading to impairment in daily activity and quality of life. Patients with severe and very severe disease are at a higher risk for negative outcomes, including exacerbation (up to 2-3 per patient per year). This in turn increases the risk of future exacerbations and mortality, with heightened risk lasting up to two years after each event. It is impertive to evaluate which sub-groups are at an even higher risk and could be potential targets for intervention. The PLATINO study was conducted on 2004 and evaluated the prevalence of COPD in 5 cities, only one in Brazil - Sao Paulo. As the data is 20 years old it might not reflect the current epidemiological status and might not be representative of Brazil as a whole. Understanding this population, their clinical and laboratorial characteristics can help identify sub-groups with higher risk and potential for intervention. The current prevalence, causing agent and characteristics are not known in Brazil as well as detailed outcome data.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Severe, very severe and symptomaitc COPD, according to GOLD definition: exposure, FEV1/FVC ratio \<0,7:

• GOLD B (mMRC\>=2, CAT\>=10), OR

• GOLD E (\>=2 moderate exacerbations or 1 severe), OR

• GOLD 3 and 4 (FEV1 \<50%).

Locations
Other Locations
Brazil
Hospital Israelita Albert Einstein (HIAE)
RECRUITING
São Paulo
Contact Information
Primary
Francisco JN Mazon, MD
francisco.mazon@einstein.br
+55 11 21511233
Backup
Henrique A R Fonseca, ScD
henrique.fonseca@einstein.br
+55 11 21511233
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 693
Treatments
GOLD B; OR GOLD E
Criteria: CAT ≥10 or MMRC ≥ 2 ; OR 2 exacerbations/year or 1 exacerbation leading to hospitalization
GOLD 3 OR 4
Criteria: FVE1 \< 50%
Sponsors
Leads: Hospital Israelita Albert Einstein

This content was sourced from clinicaltrials.gov